Application 079172
- Type
- ANDA
- Sponsor
- GLENMARK PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 5MG | No | No |
| 002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 10MG | No | No |
| 003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 20MG | No | No |
| 004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | TABLET;ORAL | 40MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A079172-001 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | |
| A079172-002 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | |
| A079172-003 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | |
| A079172-004 | ROSUVASTATIN CALCIUM | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A079172-001 | AB |
| A079172-002 | AB |
| A079172-003 | AB |
| A079172-004 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A079172-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A079172-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A079172-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A079172-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A079172-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079172-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079172-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A079172-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079172-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079172-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079172-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A079172-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079172-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079172-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079172-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079172-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079172-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079172-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079172-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A079172-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079172-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079172-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079172-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079172-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079172-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079172-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079172-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079172-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079172-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079172-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079172-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079172-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079172-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079172-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079172-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079172-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079172-001 | ROSUVASTATIN CALCIUM | EQ 5MG BASE | TABLET / ORAL | AB | 2016-07-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079172-002 | ROSUVASTATIN CALCIUM | EQ 10MG BASE | TABLET / ORAL | AB | 2016-07-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079172-003 | ROSUVASTATIN CALCIUM | EQ 20MG BASE | TABLET / ORAL | AB | 2016-07-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079172-004 | ROSUVASTATIN CALCIUM | EQ 40MG BASE | TABLET / ORAL | AB | 2016-07-19 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A079172-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A079172-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A079172-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A079172-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A079172-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079172-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079172-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A079172-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A079172-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079172-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079172-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A079172-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079172-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079172-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079172-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A079172-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A079172-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079172-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079172-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A079172-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079172-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079172-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079172-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A079172-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079172-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079172-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079172-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A079172-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079172-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079172-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079172-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A079172-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079172-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079172-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079172-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A079172-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079172-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079172-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079172-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A079172-004 | AB | 1 | 5bbf6a4d5a75… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | 0ffb16d3-e14a-4d4e-9cbe-af9534ec1735 | 2024-01-07 | Warnings, Adverse reactions | 079172 ANDA079172 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | 4a2abf58-ef55-46f4-a6bc-bc87bb88df78 | 2023-12-03 | Warnings, Adverse reactions | 079172 ANDA079172 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | A-S Medication Solutions | 2aa6d21f-426a-42b0-aa96-4cc47f97f7ab | 2023-02-06 | Warnings, Adverse reactions | 079172 ANDA079172 50090-4738 |
| Rosuvastatin Calcium | ROSUVASTATIN CALCIUM | Proficient Rx LP | c40d5c38-3585-47ed-ad81-6ad2da91c9c8 | 2022-04-01 | Warnings, Adverse reactions | 079172 ANDA079172 71205-279 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-988 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-988 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-988 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-988 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-988 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-989 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-989 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-989 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-989 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-989 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-990 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-990 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-990 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-990 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-990 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-991 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-991 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-991 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-991 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 16714-991 | Rosuvastatin Calcium | Rosuvastatin Calcium | NorthStar RxLLC | ANDA | Current |
| 50090-3515 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-3515 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-3515 | Rosuvastatin Calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 50090-3549 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-3549 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-4738 | Rosuvastatin Calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 50090-4738 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-4738 | Rosuvastatin Calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 50090-5056 | Rosuvastatin calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 50090-5745 | Rosuvastatin Calcium | Rosuvastatin Calcium | A-S Medication Solutions | ANDA | Current |
| 50090-6302 | Rosuvastatin calcium | Rosuvastatin calcium | A-S Medication Solutions | ANDA | Current |
| 55700-839 | Rosuvastatin Calcium | Rosuvastatin Calcium | Quality Care Products, LLC | ANDA | Current |
| 55700-839 | Rosuvastatin Calcium | Rosuvastatin Calcium | Quality Care Products, LLC | ANDA | Current |
| 55700-885 | Rosuvastatin calcium | Rosuvastatin calcium | Quality Care Products, LLC | ANDA | Current |
| 55700-885 | Rosuvastatin calcium | Rosuvastatin calcium | Quality Care Products, LLC | ANDA | Current |
| 55700-885 | Rosuvastatin calcium | Rosuvastatin calcium | Quality Care Products, LLC | ANDA | Current |
| 68071-2760 | Rosuvastatin Calcium | Rosuvastatin Calcium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68462-261 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-261 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-261 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-261 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-261 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-261 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-261 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-262 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-262 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-262 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-262 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-262 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-262 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-262 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-263 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-263 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-263 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-263 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-263 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-263 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-263 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-264 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-264 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-264 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-264 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-264 | Rosuvastatin Calcium | Rosuvastatin Calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-264 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 68462-264 | Rosuvastatin calcium | Rosuvastatin calcium | Glenmark Pharmaceutials Inc., USA | ANDA | Current |
| 71205-279 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 71205-279 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 71205-279 | Rosuvastatin Calcium | Rosuvastatin Calcium | Proficient Rx LP | ANDA | Current |
| 71335-1501 | Rosuvastatin Calcium | Rosuvastatin Calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1501 | Rosuvastatin calcium | Rosuvastatin calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1717 | Rosuvastatin calcium | Rosuvastatin calcium | Bryant Ranch Prepack | ANDA | Current |
| 71335-1717 | Rosuvastatin calcium | Rosuvastatin calcium | Bryant Ranch Prepack | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 31422 | ORIG | 2016-07-20 |